chesapeake irb: risk and harm in research

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Risk and Harm in Research Chesapeake IRB Copyright 2015 Chesapeake IRB

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Page 1: Chesapeake IRB: Risk and Harm in Research

Risk and Harm in Research

Chesapeake IRB

Copyright 2015 Chesapeake IRB

Page 2: Chesapeake IRB: Risk and Harm in Research

Assessment of Risks and Benefits

•  An opportunity and a responsibility

For the researcher: a means to examine whether research is properly designed

For the IRB: a method for determining whether risks to subjects are justified

For the prospective subjects: assistance in determining whether or not to participate

Copyright 2015 Chesapeake IRB

Page 3: Chesapeake IRB: Risk and Harm in Research

Important Concepts

•  Risk: refers to the probability that some type of harm will occur

•  Harm: refers to some outcome or event that has a level of magnitude (e.g., mere inconvenience, serious illness)

•  Benefit: refers to something of positive value related to health or welfare

Copyright 2015 Chesapeake IRB

Page 4: Chesapeake IRB: Risk and Harm in Research

Risk <≠> Benefits

Proper Contrasts :

Harms ó Benefits Risk of harms ó Probability of benefits

Magnitude of harms ó Magnitude of benefits

Copyright 2015 Chesapeake IRB

Page 5: Chesapeake IRB: Risk and Harm in Research

Types of Benefits

•  Gain to society or science through contribution to the knowledge base

•  Gain to the individual –  Through improved well-being, or –  Through empowerment of the individual by giving

him/her a voice

Copyright 2015 Chesapeake IRB

Page 6: Chesapeake IRB: Risk and Harm in Research

Types of Harm

•  Mere inconvenience •  Emotional harm: distress, embarrassment, trauma •  Physical harm: from a research procedure or from

from those who would harm the subject for participating

•  Social harm: disclosure leads to stigma, rejection of subject, persecution, loss of social status

•  Economic Harm: Economic costs due to efforts to avoid or recover from other harms, loss of employment

Copyright 2015 Chesapeake IRB

Page 7: Chesapeake IRB: Risk and Harm in Research

Sources of Harm

•  Participation in research: reaction to materials or procedures; mere contact

•  Breach of Confidentiality: Disclosure of information from subjects’ participation in research

•  Socioeconomic: The impact of the research project after its completion

Copyright 2015 Chesapeake IRB

Page 8: Chesapeake IRB: Risk and Harm in Research

“Minimal Risk”

•  The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests

Copyright 2015 Chesapeake IRB

Page 9: Chesapeake IRB: Risk and Harm in Research

The “Daily Life” Standard

•  Routine physical or psychological tests –  Some discomfort or stress –  Low magnitude –  Transient, short duration

•  Daily life encounters –  Hassles, arguments, minor accidents that happen to

most people over a couple of years

Copyright 2015 Chesapeake IRB

Page 10: Chesapeake IRB: Risk and Harm in Research

Interpreting “Risk”

•  “Low-risk” refers to research where the worst harm possible is low-magnitude and transient, whether or not it is likely to occur

•  “Minimal risk” refers to research where the worst harm likely is not very serious, and if it is, the probability of a subject experiencing it is extremely low

•  “Greater than minimal risk” is all other research

Copyright 2015 Chesapeake IRB

Page 11: Chesapeake IRB: Risk and Harm in Research

Minimizing Risk

•  Alternatives –  Substitute other procedures that are less risky

•  Precautions –  Incorporate procedures to decrease the likelihood that

harms will occur •  Safeguards

–  Incorporate procedures to deal with harms if they do occur

Copyright 2015 Chesapeake IRB

Page 12: Chesapeake IRB: Risk and Harm in Research

Chesapeake IRB

Human Connection >>>Technology Driven

Thank you

www.chesapeakeirb.com www.irbservices.com

www.cirbi.net

Contact Us

Ruth Boulter - 609-731-8786

Ron Di Nofa - 609- 751-6417

Ellen Kelso - 513-218-9699

Copyright 2015 Chesapeake IRB